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Not yet recruiting NCT05031260

COMORAL® the Oral Irrigation Unit Clinical Trial

No phase Interventional Gingivitis Plaque

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: applying COMORAL®.
Who it may be relevant to
Registry conditions: Gingivitis, Plaque. Basic parameters: 18 years — 25 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effect of COMORAL® the Oral Irrigation Unit in Preventing Gingivitis and Plaque Formation

Overview

This is a clinical study to evaluate the safety and effectiveness of COMORAL®, the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. To do so, 42 healthy subjects, 21 control and 21 experimental, will be recruited. To establish the baseline, all subjects will receive dental hygiene service. After 2 weeks, patients will be randomly assigned to either control or intervention group (21 individuals each). Both groups will be asked to brush their teeth once a day but without dental floss, mouth rinse, and gum chewing, throughout the 4 weeks of study period. During the study period, the experimental group will receive COMORAL® treatment three times a day every day for 4 weeks except Saturday and Sunday. Subjects will get evaluated for the oral status(PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1, visit 2 and visit 3.

Detailed description

This is a randomized, open-labeled, single-centered clinical study to evaluate COMORAL® the intraoral water-spraying cleaning device that is developed to remove plaque around teeth in the oral cavity. The purpose of this clinical study is to evaluate the safety and effectiveness of COMORAL® the oral irrigation unit in preventing gingivitis and plaque formation in adult patients.

42 patients between 18 to 25 years old who have a periodontal probing depth of 3 mm or less will be recruited. To establish the baseline, all the patients will receive dental hygiene service.

After 2 weeks (Visit 1), patients will be randomly assigned to either control or intervention group (21 individuals each). They will be asked to do the following instruction; Control group (21 total) - The individuals in the control group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum.

Experimental/Intervention group (21 total) - The individuals in this group will be asked to brush their teeth once a day at home throughout the 4 weeks of study period. They will be asked not to use the supplementary oral hygiene products including mouth rinse, dental floss and chewing gum. Instead, they will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.

Subjects in both groups will be evaluated for clinical indices (PI, BOP, GI, PD, GR, CAL) and the status of periopathogens on visit 1(baseline, visit 2(after 2 weeks), and visit 3(after 4 weeks). To measure the status of periopathogens, 3ml of saliva will be collected from each subject.

Interventions

  • Device applying COMORAL®
    The individuals in the experimental group will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.

Primary outcome measures

  • gingival index (GI) [Time frame: Baseline, 2 weeks, 4 weeks]
  • plaque index (PI) [Time frame: Baseline, 2 weeks, 4 weeks]
  • bleeding on probing (BOP) [Time frame: Baseline, 2 weeks, 4 weeks]
  • pocket depth (PD) [Time frame: Baseline, 2 weeks, 4 weeks]
  • gingival recession (GR) [Time frame: Baseline, 2 weeks, 4 weeks]
  • clinical attachment loss (CAL) [Time frame: Baseline, 2 weeks, 4 weeks]
Secondary outcome measures (1)
  • Periopathogens (PP) [Time frame: Baseline, 2 weeks, 4 weeks]

Eligibility criteria

Inclusion criteria

  • Healthy adult patients (ASA 1-2) aged 18 to 25 with a probing depth of 3mm or less
  • Those with 3 or more natural teeth in each quartile
  • Those who can voluntarily sign the consent form

Exclusion criteria

  • Existing dental caries
  • Existing periodontitis
  • Other oral diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05031260 · 20-001256

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗